Evaluation of the Prevention of Thromboembolic Disease in Patients With a Lower Limb Trauma, Non Surgical, in Winter Sports Resort

NCT01303523 | Completed DMC

• 1 other identifier: DCIC
• Study Type: observational
• Target: 1,627
• Locations: 1 country
• Sites: 28

Brief Summary

The purpose of this study is to evaluate the impact of thromboembolic diseases and heparin complications in patients with a lower limb trauma supported by physicians of mountain.

Conditions

Leg Injuries; Winter Sport Resorts; Outpatients

Keywords

LMWH; heparin; immobilization; anticoagulant prophylaxis; leg injuries; thromboembolism

Outcome Measures

Primary Outcomes (1)

• impact of a thromboembolic disease and heparin's complications

  Evaluation of the impact of a thromboembolic disease and heparin's complications in outpatients with a lower limb trauma are supported by physicians in winter sports resort. The patients will be contacted by phone 3 months after trauma to collect these data.

  3 months

Secondary Outcomes (4)

• compliance with the algorithm for prescribing heparin and consequences on the primary endpoint

  3 months

• incidence of thromboembolic diseases and heparin complications in different subgroups

  3 months

• Description of the included patients

  evaluation during inclusion visit

• Epidemiological characteristics of patients with a thromboembolic event or an adverse effect of the treatment

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

outpatients with a lower limb trauma, in winter sports resorts

You may qualify if:

• patients seen during a consultation with a physician of mountain
• lower limb trauma seen within 48 hours
• patient resident in France

You may not qualify if:

• conditions requiring an immediate hospitalization
• prisoners
• pregnant, nursing or parturient woman
• refused participation in follow-up

Sponsors & Collaborators

• Floralis: lead
• University Hospital, Grenoble: collaborator

Study Sites (28)

medical center "Le chevreuil"

Autrans, 38880, France

Location

Medical center "le pas du lac"

Avoriaz, 74110, France

Location

Medical center "les Soldanelles"

Bellevaux, 74470, France

Location

Medical center "le serre d'aigle"

Chantemerle, 05330, France

Location

Medical center of Combloux

Combloux, 74920, France

Location

Medical home

Flaine, 74300, France

Location

Medical center of flumet

Flumet, 73590, France

Location

Medical Center Brousse

Font-Romeu-Odeillo-Via, 66120, France

Location

Medical center of Beauregard - "les cyclamens"

La Clusaz, 74220, France

Location

Medical group "le Yéti"

La Clusaz, 74220, France

Location

Medical center

Lanslevillard, 73480, France

Location

Medical group "SELARL Sports médecine montagne"

Le Grand-Bornand, 74450, France

Location

Medical group of Peric

Les Angles, 66210, France

Location

Medical center of "Aiguille rouge"

Les Arcs, 73700, France

Location

Medical center "Val Montjoie"

Les Contamines-Montjoie, 74170, France

Location

SCP medical "le Bennevy"

Les Gets, 74260, France

Location

Medical center

Les Orres, 05200, France

Location

Medical center

Lullin, 74470, France

Location

Medical center of Jaillet

Megève, 74120, France

Location

Medical center of Peisey-Vallandry

Peisey Vallandry, 73210, France

Location

Resort of Peyragudes

Peyragudes, 65240, France

Location

Medical center "le rocher de l'aigle"

Saint-François-Longchamp, 73130, France

Location

Medical center "Fleur des alpes"

Saint-Gervais-les-Bains, 74170, France

Location

Medical center

Samoëns, 74340, France

Location

Medical center "medival"

Val-d'Isère, 73150, France

Location

Medical center of Valberg

Valberg Guillaumes, 06470, France

Location

Medical center

Vallouise, 05290, France

Location

Medical center

Villard-de-Lans, 38250, France

Location

Related Publications (11)

• Motykie GD, Zebala LP, Caprini JA, Lee CE, Arcelus JI, Reyna JJ, Cohen EB. A guide to venous thromboembolism risk factor assessment. J Thromb Thrombolysis. 2000 Apr;9(3):253-62. doi: 10.1023/a:1018770712660. No abstract available.

  PMID: 10728025 BACKGROUND

• Edelsberg J, Ollendorf D, Oster G. Venous thromboembolism following major orthopedic surgery: review of epidemiology and economics. Am J Health Syst Pharm. 2001 Nov 1;58 Suppl 2:S4-13. doi: 10.1093/ajhp/58.suppl_2.S4.

  PMID: 11715837 BACKGROUND

• Lijfering WM, Rosendaal FR, Cannegieter SC. Risk factors for venous thrombosis - current understanding from an epidemiological point of view. Br J Haematol. 2010 Jun;149(6):824-33. doi: 10.1111/j.1365-2141.2010.08206.x. Epub 2010 Apr 29.

  PMID: 20456358 BACKGROUND

• Gensini GF, Prisco D, Falciani M, Comeglio M, Colella A. Identification of candidates for prevention of venous thromboembolism. Semin Thromb Hemost. 1997;23(1):55-67. doi: 10.1055/s-2007-996071.

  PMID: 9156412 BACKGROUND

• Eschwege V, Robert A. Strikes in French public transport and resistance to activated protein C. Lancet. 1996 Jan 20;347(8995):206. doi: 10.1016/s0140-6736(96)90393-1. No abstract available.

  PMID: 8544587 BACKGROUND

• Vaitkus PT, Leizorovicz A, Goldhaber SZ; PREVENT Investigator Group. Rationale and design of a clinical trial of a low-molecular-weight heparin in preventing clinically important venous thromboembolism in medical patients: the prospective evaluation of dalteparin efficacy for prevention of venous thromboembolism in immobilized patients trial (the PREVENT study). Vasc Med. 2002;7(4):269-73. doi: 10.1191/1358863x02vm449oa.

  PMID: 12710842 BACKGROUND

• Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.

  PMID: 16439370 BACKGROUND

• Kujath P, Spannagel U, Habscheid W. Incidence and prophylaxis of deep venous thrombosis in outpatients with injury of the lower limb. Haemostasis. 1993 Mar;23 Suppl 1:20-6. doi: 10.1159/000216905.

  PMID: 8388353 BACKGROUND

• Jorgensen PS, Warming T, Hansen K, Paltved C, Vibeke Berg H, Jensen R, Kirchhoff-Jensen R, Kjaer L, Kerbouche N, Leth-Espensen P, Narvestad E, Rasmussen SW, Sloth C, Torholm C, Wille-Jorgensen P. Low molecular weight heparin (Innohep) as thromboprophylaxis in outpatients with a plaster cast: a venografic controlled study. Thromb Res. 2002 Mar 15;105(6):477-80. doi: 10.1016/s0049-3848(02)00059-2.

  PMID: 12091045 BACKGROUND

• Lassen MR, Borris LC, Nakov RL. Use of the low-molecular-weight heparin reviparin to prevent deep-vein thrombosis after leg injury requiring immobilization. N Engl J Med. 2002 Sep 5;347(10):726-30. doi: 10.1056/NEJMoa011327.

  PMID: 12213943 BACKGROUND

• Riou B, Rothmann C, Lecoules N, Bouvat E, Bosson JL, Ravaud P, Samama CM, Hamadouche M. Incidence and risk factors for venous thromboembolism in patients with nonsurgical isolated lower limb injuries. Am J Emerg Med. 2007 Jun;25(5):502-8. doi: 10.1016/j.ajem.2006.09.012.

  PMID: 17543652 BACKGROUND

MeSH Terms

Conditions

Leg Injuries; Thromboembolism

Condition Hierarchy (Ancestors)

Wounds and Injuries; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dominique LAMY, MD

  Médecins de Montagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

FR (28)